MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID

Model Number	UNKNOWN
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2004
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient previously had open ascending repair and relevant medical history of dissection.Post operative to that procedure (uk dos) patient developed additional type a dissection at anastomosis line and additional tear at apex of the arch.Patient showed on that scan a compressed tl with the tl on the inner curve of the arch.Distal landing zone was estimated at 150mm from zone 2 where the scan showed the tlmax = 29mm and aortic outer wall diameter averaging 36mm.Thus a 30/32/150mm plexus was chosen as the device size for fet.Patient was evaluated for fet/total arch repair which was performed on (b)(6) 2024 with 30/32/150mm plexus configuration at zone 2.Post operative scan from (b)(6) 2024 indicated graft was severely compressed in the tl.Physician is consulting with vascular partner to consider adjunctive ballooning and/or future tevar.Patient outcome no clinical sequalae has been communicated other than radiologic finding of graft compression/collapse.
Additional Manufacturer Narrative
Clinical code: 4580 insufficient information: a/w scans and additional information from site.Impact code: 4624 surgical intervention: patient was evaluated for fet/total arch repair which was performed on (b)(6) 2024 with 30/32/150mm plexus configuration at zone 2.Post operative scan from (b)(6) 2024 indicated graft was severely compressed in the tl.Physician is consulting with vascular partner to consider adjunctive ballooning and/or future tevar.Medical device problem: 3190 insufficient information: a/w scans and additional information from site.Component code: 4755 part/component/sub-assembly term not applicable.Type of investigation: 4110 trend analysis: a 5 year review of similar complaints (appearance > product defect > other) gave an occurrence rate of less than (b)(4) (complaints v sales).No negative trend in the number of complaints received has been identified.4111 communication/interviews: a/w scans and additional information from site.3331 analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.4114 device not returned: device remains implanted.
Event or Problem Description
Patient previously had open ascending repair and relevant medical history of dissection.Post operative to that procedure (uk dos) patient developed additional type a dissection at anastomosis line and additional tear at apex of the arch.Patient showed on that scan a compressed tl with the tl on the inner curve of the arch.Distal landing zone was estimated at 150mm from zone 2 where the scan showed the tlmax = 29mm and aortic outer wall diameter averaging 36mm.Thus a 30/32/150mm plexus was chosen as the device size for fet.Patient was evaluated for fet/total arch repair which was performed on 1/17/24 with 30/32/150mm plexus configuration at zone 2.Post operative scan from 1/21/24 indicated graft was severely compressed in the tl.Physician is consulting with vascular partner to consider adjunctive ballooning and/or future tevar.Patient outcome no clinical sequalae has been communicated other than radiologic finding of graft compression/collapse.This report has been submitted as a final for mfg.Report fda 9612515-2024-00008 to provide investigation outcome details.
Additional Manufacturer Narrative
Clinical code 4582 - patient showed no clinical signs, symptoms or conditions.No clinical sequalae has been communicated other than radiologic finding of graft compression/collapse impact code: 4624 surgical intervention: patient was evaluated for fet/total arch repair which was performed on (b)(6) 2024 with 30/32/150mm plexus configuration at zone 2.Post operative scan from (b)(6) 2024 indicated graft was severely compressed in the tl.Physician is consulting with vascular partner to consider adjunctive ballooning and/or future tevar.Product was ballooned and additional stent was placed (not a terumo stent).That procedure was done because of the radiographic images showing the graft compressed.Medical device problem: 1583 - inadequacy of device size / shape due to patient anatomy.Scans provided showed the device used was not compatible with the patients anatomy causing compression of the device.Component code: 4755 part/component/sub-assembly term not applicable.Type of investigation: 4110 trend analysis: a 5 year review of similar complaints (appearance > product defect > other) gave an occurrence rate of less than 0.000% (complaints v sales).No negative trend in the number of complaints received has been identified.4111 communication/interviews: scans were provided for review.3331 analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device 4114 device not returned: device remains implanted.Investigation findings: 213 - no device problem found - the incident was found to be not device related.Scans provided showed the device used was not compatible with the patients anatomy causing compression of the device.Investigation conclusions: 4310 - not device related - the incident was found to be not device related.Scans provided showed the device used was not compatible with the patients anatomy causing compression of the device.

• Brand Name: THORAFLEX HYBRID
• Common Device Name: THORAFLEX HYBRID
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 18729299
• Report Number: 9612515-2024-00008
• Device Sequence Number: 12809942
• Product Code: QSK
• UDI-Device Identifier: 05037881026824
• UDI-Public: 05037881026824
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P210006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: THP3032X150A-G
• Device Lot Number: 25368931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2024
• Supplement Date Received by Manufacturer: 01/21/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male